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Study to Evaluate the Safety and Efficacy of Tafasitamab Plus Lenalidomide in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (firmMIND)
Sponsor: Incyte Corporation
Summary
The purpose of this study is to assess the efficacy and safety of of tafasitamab plus lenalidomide in adults with diffuse large B-cell lymphoma (DLBCL) who have relapsed or are refractory to at least 1 but no more than 3 previous systemic DLBCL treatment regimens and who are not eligible for high-dose chemotherapy (HDC) and autologous stem cell transplantation (ASCT).
Official title: A Phase 3, Single-Arm, Open-Label, Multicenter Study to Evaluate the Safety and Efficacy of Tafasitamab Plus Lenalidomide in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Key Details
Gender
All
Age Range
18 Years - 99 Years
Study Type
INTERVENTIONAL
Enrollment
82
Start Date
2022-12-23
Completion Date
2027-04-01
Last Updated
2025-12-10
Healthy Volunteers
No
Interventions
Tafasitamab
Tafasitamab will be administered intravenously in 28-day cycles. During Cycles 1 through 3, tafasitamab will be administered weekly on Days 1, 8, 15, and 22; an additional loading dose will be administered on Cycle 1 Day 4. Starting with Cycle 4, tafasitamab will be administered on Days 1 and 15 of each cycle.
Lenalidomide
Participants will self-administer lenalidomide capsules orally on Days 1-21 of each 28-day cycle, up to 12 cycles.
Locations (61)
Medical University Plovdiv
Plovdiv, Bulgaria
Acibadem Cityclinica Mhat Tokuda
Sofia, Bulgaria
Umhat Alexandrovska Sofia
Sofia, Bulgaria
Umhat Sv. Ivan Rilski Ead
Sofia, Bulgaria
Specialized Hospital For Active Treatment of Oncological Diseases - Sofia District Eood
Sofia, Bulgaria
Clinical Hospital Dubrava
Zagreb, Croatia
Clinical Hospital Merkur
Zagreb, Croatia
University Hospital Centre Zagreb
Zagreb, Croatia
Fakultni Nemocnice Olomouc
Olomouc, Czechia
Vseobecna Fakultni Nemocnice
Prague, Czechia
Aarhus University Hospital
Aarhus, Denmark
Odense University Hospital
Odense, Denmark
Helsinki University Central Hospital
Helsinki, Finland
Kuopio University Hospital
Kuopio, Finland
Oulu University Hospital
Oulu, Finland
Tampere University Hospital
Tampere, Finland
Turku University Hospital
Turku, Finland
Semmelweis Egyetem
Budapest, Hungary
National Institute of Oncology
Budapest, Hungary
University of Debrecen
Debrecen, Hungary
Markhot Ferenc Korhaz
Eger, Hungary
Somogy Medyei Kaposi Mor Oktato Korhaz
Kaposvár, Hungary
Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza
Szeged, Hungary
Bon Secours Hospital
Cork, Ireland
Mater Misericordiae University Hospital
Dublin, Ireland
University Hospital Galway
Galway, Ireland
Rambam Health Care Campus
Haifa, Israel
Shaare Zedek Mc
Jerusalem, Israel
Hadassah University Hospital
Jerusalem, Israel
Meir Medical Center
Kefar Sava, Israel
Akershus University Hospital
Lorenskog, Norway
Universitetssykehuset I Trondheim - St. Olavs Hospital
Trondheim, Norway
Szpital Uniwersytecki Nr 2 Im Dr. Jana Biziela
Bydgoszcz, Poland
Medical University of Gdansk
Gdansk, Poland
Szpital Morski Im. Pck Sp. Z O.O
Gdynia, Poland
University Public Hospital Nr 1
Lublin, Poland
Oddzia Kliniczny Hematologii
Olsztyn, Poland
Pratia Poznan
Skórzewo, Poland
Maria Sklodowska-Curie National Research Institute of Oncology
Warsaw, Poland
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego
Wroclaw, Poland
Coltea Clinical Hospital
Bucharest, Romania
Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca
Cluj-Napoca, Romania
Institutul Regional de Oncologie Iasi
Iași, Romania
Spitalul Clinic Judetean de Urgenta Targu Mures
Târgu Mureş, Romania
Clinic For Hematology, University Clinical Center Serbia
Belgrade, Serbia
Institute For Pulmonary Diseases of Vojvodina
Kamenitz, Serbia
Clinical Center Kragujevac
Kragujevac, Serbia
Clinic of Hematology Clinical Center of Vojvodina
Novi Sad, Serbia
Hacettepe University Cancer Institute Clinical Oncology Department
Ankara, Turkey (Türkiye)
Gazi University Hospital Gazi University Faculty of Medicine
Ankara, Turkey (Türkiye)
Ankara University Medical Faculty
Ankara, Turkey (Türkiye)
Ozel Liv Hospital Onkoloji Klinigi
Ankara, Turkey (Türkiye)
Tekrda-Nk Tp Fakltesi
Center, Turkey (Türkiye)
Vkf American Hospital
Istanbul, Turkey (Türkiye)
Marmara Universitesi Pendik Egitim
Istanbul, Turkey (Türkiye)
Ege University Hospital
Izmir, Turkey (Türkiye)
Ercyes University Medical School
Kayseri, Turkey (Türkiye)
Mersin University Medical Faculty
Mersin, Turkey (Türkiye)
Dr. Abdurrahman Yurtaslan Onkology Teaching and Research Hospitalerciyes Universitesi Tip Faklutesi
Yenimahalle, Turkey (Türkiye)
Antrim Area Hospital Northern Health Social Care Trust
Antrim, United Kingdom
Belfast Health and Social Care Trust, of Trust Headquarters
Belfast, United Kingdom